Methods and materials for reducing the risk of infections

ABSTRACT

This document relates to methods and materials for reducing the risk of infection after a shoulder surgery or medical procedure. For example, this document relates to methods and materials for using a topical composition containing clindamycin or erythromycin to reduce the risk of or to prevent infection associated with shoulder surgeries or medical procedures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 61/550,765, filed Oct. 24, 2011. The disclosure of the priorapplication is considered part of (and is incorporated by reference in)the disclosure of this application.

BACKGROUND

1. Technical Field

This document relates to methods and materials for reducing the risk ofinfection after a surgery (e.g., a shoulder surgery or medicalprocedure). For example, this document relates to methods and materialsfor using a topical antibacterial composition containing clindamycin orerythromycin to reduce the risk of or prevent infections associated withshoulder medical procedures. In some cases, topical administration of atopical composition containing clindamycin or erythromycin can becarried out before, during, and after surgery.

2. Background Information

Propionibacterium acnes has become recognized as the primary organismresponsible for infection after shoulder surgery. This has beendocumented in multiple studies of infection after rotator cuff surgery,shoulder replacement surgery, instability surgery of the shoulder,clavicle fractures, proximal humerus fractures, and mid-shaft humerusfractures. Additionally, studies have shown that Prop. acnes isessentially nonexistent in native shoulder sepsis. Currently, DuraPrep™Surgical Solution (3M) or ChloraPrep® Solution (CareFusion) is used toprepare the arm for surgery. Following skin preparation, the operativeregion is then wrapped in a 3M Ioban™ drape.

SUMMARY

This document provides methods and materials for reducing the risk of orpreventing post-operative infection (e.g., post-operative shouldersurgery infection). In some cases, it is possible that Prop. acnes canbe introduced into a shoulder wound at the time of surgery, and despitethe use of skin preparation solutions and barrier drapes, a significantproblem of bacteria contamination may exist. The methods and materialsprovided herein can be used to reduce the risk of or to preventpost-operative infection (e.g., post-operative shoulder surgeryinfection such as a post-operative shoulder surgery Prop. acnesinfections). As described herein, topical administration of anantibacterial composition pre-, intra-, and post-operatively can be usedto reduce the risk of or to prevent post-operative shoulder surgeryinfection (e.g., post-operative shoulder surgery Prop. acnesinfections). In some cases, such an antibacterial composition caninclude clindamycin, erythromycin, or a combination of clindamycin anderythromycin.

In general, one aspect of this document features a method for reducingrisk of post-operative infection. The method comprises, or consistessentially of, (a) applying a first topical antibacterial compositionto at least a portion of an operative site before an operativeintervention, and (b) applying a second topical antibacterialcomposition to at least a portion of the operative site immediatelybefore the operative intervention, wherein the first and second topicalantibacterial compositions comprise clindamycin, erythromycin, or acombination thereof The operative intervention can be a shoulderinjection. The operative intervention can be a shoulder surgery. Theshoulder surgery can be selected from the group consisting of rotatorcuff surgery, shoulder replacement surgery, instability surgery of theshoulder, clavicle fracture surgery, proximal humerus fracture surgery,and mid-shaft humerus fracture surgery.

The first topical antibacterial composition can be applied multipletimes before the surgical intervention. The first topical antibacterialcomposition can be applied using a deodorant applicator. The firsttopical antibacterial composition can be applied by wiping the skin witha wipe impregnated with the first topical antibacterial composition. Themethod can further comprise dressing the surgical site post-operativelywith dressings that are impregnated with a third topical antibacterialcomposition comprising clindamycin. The first, second, or third topicalantibacterial composition can further comprise clindamycin orerythromycin and a second antibiotic.

In another aspect, this document features a surgical drape forpreventing post-operative infection. The drape can be impregnated with atopical antibacterial composition comprising clindamycin, erythromycin,or a combination thereof

In another aspect, this document features a method for reducing risk ofpost-operative infection. The method comprises, or consists essentiallyof, (a) instructing a patient to apply a first topical antibacterialcomposition to at least a portion of an operative site before anoperative intervention, (b) intra-operatively applying a second topicalantibacterial composition to at least a portion of the operative site,and (c) instructing the patient to apply a third topical antibacterialcomposition to at least a portion of the operative site after theoperative intervention, wherein the first, second, and third topicalantibacterial compositions comprise clindamycin, erythromycin, or acombination thereof.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention pertains. Although methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, suitable methods andmaterials are described below. All publications, patent applications,patents, and other references mentioned herein are incorporated byreference in their entirety. In case of conflict, the presentspecification, including definitions, will control. In addition, thematerials, methods, and examples are illustrative only and not intendedto be limiting.

Other features and advantages of the invention will be apparent from thefollowing detailed description, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of a patient's torso with an arm extendedin a traditional shoulder surgery position.

FIG. 2 is a flow chart of an exemplary process by which particularantimicrobial or antibacterial compositions or particular combinationsof antimicrobial or antibacterial compositions for reducing the risk ofor preventing a post-operative infection can be selected.

FIG. 3 is a diagram of an example of a generic computer device and ageneric mobile computer device that can be used as described herein.

DETAILED DESCRIPTION

This document provides methods and materials for reducing the risk of orpreventing post-operative infection (e.g., post-operative shouldersurgery infection). For example, this document provides methods andmaterials for using a composition containing clindamycin, erythromycin,or a combination thereof to reduce the risk of or to prevent infectionfollowing a shoulder surgery or medical procedure.

The methods and materials provided herein can be used to reduce the riskof or prevent infections after any type of surgery. For example, themethods and materials provided herein can be used to reduce the risk ofor prevent post-operative infection following shoulder surgery, cardiacand thoracic surgery, abdominal and pelvic surgery, head and necksurgery, hip and knee surgery, elbow, hand, and/or wrist surgery, spinesurgery, neurosurgery, or foot and/or ankle surgery.

Examples of shoulder surgeries and medical procedures include, withoutlimitation, rotator cuff surgery, shoulder replacement surgery,instability surgery of the shoulder, clavicle fracture surgery, proximalhumerus fracture surgery, mid-shaft humerus fracture surgery,acromioplasty, distal clavicle excision, arthroscopic debridement,labral repair, a shoulder steroid injections, a shoulder anestheticinjections, or a shoulder visco-supplementation injection.

The operative site of a surgery (e.g., a shoulder surgery or medicalprocedure) refers to that skin surface area that needs to be covered bya surgical drape during the surgery (e.g., during the shoulder surgeryor medical procedure). In some cases, a general area of an operativesite 10 for a shoulder surgery is shown in FIG. 1. This area includesthe shoulder 12, upper portion of the arm 14, and axilla 16. In somecases, a surgeon can give instructions to the patient undergoing ashoulder surgery or medical procedure exactly what areas are included inthe surgical site based upon the surgery or procedure being performed.

As described herein, an antibacterial composition can be topicallyapplied to at least a portion of the operative site of the patientbefore, during, and after the surgery or procedure. An antibacterialcomposition provided herein can include clindamycin, erythromycin, orcombinations thereof. The particular antibacterial composition used forthe pre-, intra-, and post-operative application can be the samecomposition (e.g., a clindamycin composition for each application) orcan be different (e.g., a clindamycin composition for the pre- andintra-operative application and an erythromycin composition for thepost-operative application). When using clindamycin, the clindamycin inthe composition can be a pharmaceutical grade salt or ester ofclindamycin. Pharmaceutically acceptable salts, esters, or solvates ofclindamycin refer to those that possess the desired pharmacologicalactivity and which are neither biologically nor otherwise undesirable.The salts, esters, or solvates can be formed with inorganic or organicacids such as acetate, adipate, alginate, aspartate, benzoate,benzenesulfonate, bisulfate, butyrate, citrate, camphorate,camphorsulfonate, cyclopentanepropionate, digluconate, dodecylsulfate,ethanesulfonate, fumarate, glucoheptanoate, gluconate, glycerophosphate,hemisulfate, heptanoate, hexanoate, hydrochloride, hydrobromide,hydroiodide, 2-hydroxyethanesulfonate, lactate, maleate,methanesulfonate, naphthylate, 2-naphthalenesulfonate, nicotinate,oxalate, sulfate, thiocyanate, tosylate, and undecanoate.

In some cases, base salts, esters, or solvates including, withoutlimitation, ammonium salts, alkali metal salts such as lithium, sodiumand potassium salts, alkaline earth metal salts such as calcium andmagnesium salts, salt with organic bases such as dicyclohexylaminesalts, N-methyl-D-glucamine, and salts with amino acids such asarginine, lysine, and so forth can be used as described herein. In somecases, base salts, esters, or solvates can include basicnitrogen-containing groups. Such basic nitrogen-containing groups can bequarternized with agents such as (1) lower alkyl halides such as methyl,ethyl, propyl, and butyl chloride, bromides and iodides, (2) dialkylsulfates such as dimethyl, diethyl, dibutyl and diamyl sulfates, (3)long chain alkyls such as decyl, lauryl, myristyl and stearylsubstituted with one or more halide such as chloride, bromide, andiodide, and (4) aryl or arylalkyl halides such as benzyl and phenethylbromide and others.

In some cases, clindamycin phosphate (ester) or clindamycinhydrochloride (salt) can be used as described herein as pharmaceuticallyacceptable esters or salts of clindamycin due to their compatibilitywith gelling agents and extensive history of topical use.

Since erythromycin can be limited in its solubility, dermatologicsolvents such as alcohol or acetone can be used. In solution,erythromycin can rapidly degrade, even at normal room temperature.Refrigeration can be used to somewhat extend the shelf life of suchsolutions. In some cases, an erythromycin derivative or analogue can beused as described herein.

In some cases, a particular antimicrobial composition or combination ofantimicrobial compositions can be used to reduce the risk of or toprevent post-operative infection following a particular surgery. Forexample, the antimicrobial compositions or combinations of antimicrobialcompositions set forth in Table 1 can be used to reduce the risk of orto prevent post-operative infection following a particular surgery asset forth in Table 1.

TABLE 1 Antimicrobial agents for reducing the risk of or for preventinginfection following surgery. Surgery Operative Type Site MicrobialOrganisms Antimicrobial Agents Shoulder Shoulder Prop. acnesClindamycin, erythromycin, or a combination thereof Hip HipStaphylococcus aureus Mupirocin, retapamulin, or a and/or Staphylococcusepidermidis combination thereof Knee Knee Staphylococcus aureusMupirocin, retapamulin, or a and/or Staphylococcus epidermidiscombination thereof Cardiac Cardiac Staphylococcus aureus Mupirocin,retapamulin, or a and/or Staphylococcus epidermidis combination thereofSpine Spine Staphylococcus epidermidis Mupirocin, retapamulin, and/orclindamycin, erythromycin, Propionibacterium acnes or a combinationthereof Neurosurgery Spine and Staphylococcus aureus, Mupirocin,retapamulin Skull Staphylococcus epidermidis, clindamycin, erythromycin,and/or or a combination thereof Propionibacterium acnes

A composition provided herein for reducing the risk of or preventingpost-operative infection (e.g., post-operative shoulder infection) canincluded any appropriate concentration of an antimicrobial orantibacterial agent (e.g., clindamycin and/or erythromycin) thateffectively kills or reduces replication of microbes or bacteria (e.g.,Prop. Acnes). For example, a composition designed for topicaladministration can include from about 0.1% to about 5% by weight ofclindamycin and/or erythromycin.

In some cases, a topical antimicrobial or antibacterial composition caninclude one or more antimicrobial or antibacterial agents. For example,an antibacterial composition provided herein can include clindamycinand/or erythromycin in combination with any one or more of the followingagents: azelaic acid, benzyol peroxide, sodium sulfacetamide,azithromycin, clarithromycin, lincomycin, and salts thereof. In somecases, a topical antimicrobial or antibacterial composition providedherein can include a retinoid such as adapalene, tazarotene, ortretinoin.

A topical composition provided herein may take the form of a gel, cream,lotion, suspension, emulsion, ointment, foam, or mixtures thereof Othercosmetic treatment compositions known to those skilled in the art,including liquids and balms can be designed to include an antimicrobialor antibacterial agent and used as described herein. In some cases, anantimicrobial or antibacterial composition provided herein can beapplied with an applicator. Examples of applicators that can be used toapply an antimicrobial or antibacterial composition as described hereininclude, without limitation, pledgets and pads. In some cases, anantimicrobial or antibacterial composition may be incorporated into anadhesive patch or soap, or formulated such that it can be delivered withan applicator typically used to apply deodorant.

Emulsions, such as oil-in-water or water-in-oil systems, as well as abase (vehicle or carrier) for the topical formulation can be selected toprovide effectiveness of the active ingredient and/or avoid allergic andirritating reactions (e.g., contact dermatitis) caused by ingredients ofthe base or by the active ingredients.

In some case, an antimicrobial or antibacterial composition to be usedas described herein can include one or more emulsifiers. Examples ofemulsifiers useful in this regard include, without limitation, glycolesters, fatty acids, fatty alcohols, fatty acid glycol esters, fattyesters, fatty ethers, esters of glycerin, esters of propylene glycol,fatty acid esters of polyethylene glycol, fatty acid esters ofpolypropylene glycol, esters of sorbitol, esters of sorbitan anhydrides,carboxylic acid copolymers, esters and ethers of glucose, ethoxylatedethers, ethoxylated alcohols, alkyl phosphates, polyoxyethylene fattyether phosphates, fatty acid amides, acyl lactylates, soaps,polyethylene glycol 20 sorbitan monolaurate (polysorbate 20),polyethylene glycol 5 soya sterol, steareth-2, steareth-20, steareth-21,ceteareth-20, PPG-2 methyl glucose ether distearate, ceteth-10,polysorbate 80, cetyl phosphate, potassium cetyl phosphate,diethanolamine cetyl phosphate, polysorbate 60, glyceryl stearate,PEG-100 stearate, tragacanth gum, poly(acrylamide-b-acrylic acid), 10-30alkyl acrylate crosspolymers, derivatives thereof, and mixtures thereof

Creams useful in the compositions used herein can be semisolid emulsionsof oil and water. They can be easily applied and vanish when rubbed intothe skin.

Lotions useful in the compositions used herein can include suspensionsof powdered material in a water or alcohol base (e.g., calamine), aswell as water-based emulsions (e.g., some corticosteroids).

Suitable lotions or creams containing the active compound may besuspended or dissolved in, for example, a mixture of one or more of thefollowing mineral oil, sorbitan monostearate, polysorbate 60(polyoxyethylene 20 sorbitan monostearate), cetyl ester wax, cetearylalcohol, 2-octyldodecanol, benzyl alcohol, and water.

Suitable gelling agents which may be useful in the present compositionsinclude aqueous gelling agents, such as neutral, anionic, and cationicpolymers, and mixtures thereof Other suitable gelling agents includecellulosic polymers, such as gum arabic, gum tragacanth, locust beangum, guar gum, xanthan gum, cellulose gum, methylcellulose,hydroxyethylcellulose, hydroxypropylcellulose, andhydroxypropylmethylcellulose.

Other, non-limiting example of suitable thickeners useful herein includecellulosic polymers, such as gum arabic, gum acacia, gum tragacanth,locust bean gum, guar gum, hydroxypropyl guar, xanthan gum, cellulosegum, sclerotium gum, carageenan gum, karaya gum, cellulose gum, rosin,methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose,hydroxymethylcellulose, hydroxypropylmethylcellulose,methylhydroxyethylcellulose, cetyl hydroxyethylcellulose,carboxymethylcellulose, corn starch, hydroxypropyl starch phosphate,distarch phosphate, distarch dimethylene urea, aluminum starch octenylsuccinate, maltodextrin, dextran, poly(acrylamide), PEG-150 distearate,PEG-150/decyl alcohol/SMDI copolymer, PEG-150/stearyl alcohol/SMDIcopolymer, PEG-180/Laureth-50/TMMG copolymer, Polyether 1, acrylicacid/acrylamidomethyl propane sulfonic acid copolymer, acrylate/C10-30alkyl acrylate crosspolymer, acrylate/beheneth-25 methacrylatecopolymer, acrylate/steareth-20 methacrylate copolymer,acrylate/steareth-20 copolymer, acrylate/VA crosspolymer, acrylicacid/acrylonitrogen copolymer, ammoniumacryloyldimethyltaurate/beheneth-25 methacrylate copolymer, ammoniumacryloyldimethyltaurate/VP copolymer, caprylic/capric triglyceride (and)sodium acrylate copolymer, PVM/MA decadiene crosspolymer, alginic acid,propylene glycol alginate, dimethicone, silica dimethyl silylate, adimethylacrylamide/acrylic acid/polystyrene ethyl methacrylatecopolymer, derivatives thereof, and mixtures thereof Other commonthickeners and/or gelling agents, such as polyacrylic polymers, may befurther useful herein. These thickeners and/or gelling agents can bepresent in the instant compositions regardless of what form the finalcomposition takes.

Any other non-toxic, inert, and effective carrier may be used toformulate an antimicrobial or antibacterial composition. Well-knowncarriers used to formulate other therapeutic compounds foradministration to humans particularly will be useful in an antimicrobialor antibacterial composition. Pharmaceutically acceptable carriers,excipients and diluents in this regard are well known to those of skillin the art, such as those described in The Merck Index, ThirteenthEdition, Budavari et al., Eds., Merck & Co., Inc., Rahway, N.J. (2001).Examples of such useful pharmaceutically acceptable excipients,carriers, and diluents include distilled water, physiological saline,Ringer's solution, dextrose solution, Hank's solution, and DMSO.

These additional components, as well as effective formulations andadministration procedures are well known in the art and are described instandard textbooks, such as Goodman and Gillman's: The PharmacologicalBases of Therapeutics, 8th Ed., Gilman et al. Eds. Pergamon Press (1990)and Remington's Pharmaceutical Sciences, 17th Ed., Mack Publishing Co.,Easton, Pa. (1990).

Examples of excipients that can be used to formulate an antimicrobial orantibacterial composition include, without limitation, carbomers,polyacrylic polymers, glycerin, sodium hydroxide, sodium thiosulfate,propyl gallate, alkyl parabens, purified water, titanium dioxide, zincoxide, and mixtures thereof.

Other ingredients which may optionally be provided in a topicalcomposition include humectants, such as propylene glycol; solvents, suchas alcohol (de minimis); sun filters, such as titanium dioxide, zincoxide, and mixtures thereof; and anti-microbial preservatives, such asmethylparaben and propylparaben. The topical compositions may alsoinclude an organic or inorganic base, such as sodium hydroxide, which isused to adjust the pH of the initial components and the final product.

In some cases, an antimicrobial or antibacterial composition designed tobe used as described herein can additionally include remaining amountsof one or more dermatologically acceptable excipients. Examples ofdermatologically acceptable excipients useful in these compositionsinclude, without limitation, surfactants, preservatives, emollients,humectants, fluid alkyl alcohols, thickening agents, emulsifiers,suspending agents, pH modifiers/buffering agents, chelating agents,antioxidants, sun filters, derivatives thereof, and mixtures thereof

Any appropriate surfactant, preservative, emollient, humectant, fluidalkyl alcohol, thickening agent, emulsifier, suspending agent, pHmodifier, chelating agent, antioxidant, sun filter, or otherdermatologically acceptable excipient commonly known to those ofordinary skill in the art as useful in topical compositions can beincorporated into an antimicrobial or antibacterial compositionsprovided herein. In some cases, any appropriate non-toxic, inert, andeffective topical carrier may be used to formulate an antimicrobial orantibacterial composition described herein. Well-known carriers used toformulate other topical therapeutic compositions for administration tohumans will be useful in these compositions. Examples of thesecomponents that are well known to those of skill in the art aredescribed in The Merck Index, Thirteenth Edition, Budavari et al., Eds.,Merck & Co., Inc., Rahway, N.J. (2001); the CTFA (Cosmetic, Toiletry,and Fragrance Association) International Cosmetic Ingredient Dictionaryand Handbook, Tenth Edition (2004); and the “Inactive Ingredient Guide”,U.S. Food and Drug Administration (FDA) Center for Drug Evaluation andResearch (CDER) Office of Management,http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm.

Pre-operative Application

The methods for reducing the risk of or preventing post-operativeinfection from a surgery (e.g., a shoulder surgery) or medical procedurecan include a pre-operative application of a topical antimicrobial orantibacterial composition (e.g., a composition containing clindamycin,erythromycin, or a combination thereof). The antimicrobial orantibacterial composition for pre-operative application may take theform of a gel, cream, lotion, suspension, emulsion, ointment, foam, or amixture or combination thereof In one embodiment, an antimicrobial orantibacterial composition is applied using an applicator that istypically used to apply an antiperspirant and that is in widespread use.For example, an antimicrobial or antibacterial composition can be in asemi-solid stick form where the composition is accommodated within atube with one end of the stick exposed. The stick can be rubbed againstthe skin, thereby applying a small amount of the carrier material andantimicrobial or antibacterial composition. Another type of applicatorcan be a roller ball type in which the composition is received in liquidform in a container, the upper end of which affords a part-sphericalseat in which a spherical applicator ball is rotatably received. If thecontainer is inverted, and the applicator ball is rolled against theskin, the ball will rotate in its mounting, and a thin layer of anantimicrobial or antibacterial composition can be transferred from theinterior of the container to the skin on the surface of the ball.Another type of applicator can be a pressurized aerosol can orcontainer. An antimicrobial or antibacterial composition can be storedtogether with propellant in an aerosol can and can be sprayed as desiredonto the skin.

In another embodiment, an antimicrobial or antibiotic composition can beapplied using an adhesive transdermal patch such as those described inU.S. Patent Application Publication No. 2011/0105976 or 2010/0299796.The patch can be a single, large patch specifically configured to fitthe arm and shoulder area, including the axilla. In some cases, multiplesmaller patches can be used to cover the shoulder and axilla area.

In another embodiment, an antimicrobial or antibiotic composition can beformulated into a soap solution that can be used to wash the surgicalsite.

In another embodiment, an antimicrobial or antibiotic composition can beapplied using disposable cloth wipes that are impregnated with theantimicrobial or antibiotic composition.

In another embodiment, the pre-operative application of an antimicrobialor antibacterial composition can include an additional combinationtherapy. The application of an antimicrobial or composition can becombined with a separate retinoid-containing source, such as for exampletopical tretinoin (retinoic acid) in 0.025%, 0.05%, or 0.1% cream, 0.05%liquid, or 0.01% or 0.025% gel. In some cases, another topical retinoid,Differin® brand adapalene 0.1% gel (Galderma Laboratories, San Antonio,Tex.), can be used since it may be slightly less irritating than topicaltretinoin. Other retinoids, which can be used as an additional retinoidsource in combination therapy, include Panretin®, containingalitretinoin, and Targretin®, containing bexarotene.

The patient undergoing a surgery (e.g., a shoulder surgery) or medicalprocedure can be given instructions to apply the pre-operativeantimicrobial or antibacterial composition one time before the surgeryor medical procedure or multiple times before the surgery or medicalprocedure. For example, a patient can be instructed to apply anantimicrobial or antibacterial composition the night before the surgeryor medical procedure. In some cases, a patient can be instructed toapply an antimicrobial or antibacterial composition daily (or multipletimes daily) for one, two, three, four, five, six, seven, eight, nine,ten, or more days prior to the surgery or medical procedure. In somecases, a patient can be instructed to apply an antimicrobial orantibacterial composition daily (or multiple times daily) for betweenone and 14 days prior to the surgery or medical procedure. The multipletimes daily can be two, three, four, five, or more times daily.

Intra-Operative Application

The methods for reducing the risk of or preventing post-operativeinfection from a surgery (e.g., a shoulder surgery) or medical procedurecan include an intra-operative application of a topical antimicrobial orantibacterial composition (e.g., a composition containing clindamycin,erythromycin, or a combination thereof). The term “intra-operative” asused herein refers to the time from when the patient is admitted to theclinical facility (e.g., a clinic or hospital) or clinical unit (e.g.,surgery unit) for performance of the surgery or medical procedure to thetime when the surgery or medical procedure is completed. Theantimicrobial or antibacterial composition for intra-operativeapplication may take the form of a gel, cream, lotion, suspension,emulsion, ointment, foam, or a mixture or combination thereof In somecases, the intra-operative antimicrobial or antibacterial compositioncan be in the form of a liquid. The antimicrobial or antibacterialcomposition can be applied using a cotton swab or an applicator such asthe one described in U.S. Pat. No. 6,910,822. In some cases, anantibacterial composition containing clindamycin can be applied alone orin combination with DuraPrep™ Surgical Solution (3M), ChloraPrep®Solution (CareFusion), or Betadine (Purdue Frederick Co).

The intra-operative application of an antimicrobial or antibacterialcomposition can include using a surgical drape impregnated with theantimicrobial or antibacterial composition. For example, the drape canbe the Ioban drape made by 3M Healthcare.

Post-Operative Application

The methods for reducing the risk of or preventing post-operativeinfection from a surgery (e.g., a shoulder surgery) or medical procedurecan include a post-operative application of a topical antimicrobial orantibacterial composition (e.g., a composition containing clindamycin,erythromycin, or a combination thereof). The antimicrobial orantibacterial composition for intra-operative application may take theform of a gel, cream, lotion, suspension, emulsion, ointment, foam, or amixture or combination thereof The post-operative antimicrobial orantibacterial composition can be applied by impregnating the dressingsused to cover the surgical wounds with the antimicrobial orantibacterial composition. For example, an antimicrobial orantibacterial composition could be used in combination with a Mepilex®Border dressing (Mölnlycke® Health Care, Norcross, Georgia). In somecases, the post-operative antimicrobial or antibacterial composition caninclude the pre-operative antimicrobial or antibacterial compositionsdescribed above. The post-operative antimicrobial or antibacterialcomposition can be first applied or re-applied by the patient when thesurgical wound dressings are changed or after they have been removed.The post-operative antimicrobial or antibacterial composition can beapplied immediately following the surgery or medical procedure, one dayfollowing the surgery or medical procedure, or up to two weeks followingthe surgery or medical procedure.

FIG. 2 shows an exemplary process by which particular antimicrobial orantibacterial compositions or particular combinations of antimicrobialor antibacterial compositions for reducing the risk of or preventing apost-operative infection can be selected. The process begins at box 300,where information regarding the type of surgery to be performed and theoperative site of the surgery is collected. For example, a surgeon canprovide information about the particular type of surgery to be performedand information about the particular location of the operative site ofthe surgery. At box 310, data regarding antimicrobial or antibacterialcompositions or combinations of antimicrobial or antibacterialcompositions effective for reducing the risk of or preventing apost-operative infection for the type of surgery to be performed and theoperative site (e.g., data within a database) are assessed to determinepossible antimicrobial or antibacterial compositions or combinations ofantimicrobial or antibacterial compositions for the patient. At box 320,output providing an indication of possible antimicrobial orantibacterial compositions or possible combinations of antimicrobial orantibacterial compositions for the patient is formatted. Once formatted,the output can be presented to a user (e.g., a surgeon, clinician, ormedical professional).

FIG. 3 is a diagram of an example of a generic computer device 1400 anda generic mobile computer device 1450, which may be used with thetechniques described herein. Computing device 1400 is intended torepresent various forms of digital computers, such as laptops, desktops,workstations, personal digital assistants, servers, blade servers,mainframes, and other appropriate computers. Computing device 1450 isintended to represent various forms of mobile devices, such as personaldigital assistants, cellular telephones, smart phones, and other similarcomputing devices. The components shown here, their connections andrelationships, and their functions, are meant to be exemplary only, andare not meant to limit implementations of the inventions describedand/or claimed in this document.

Computing device 1400 includes a processor 1402, memory 1404, a storagedevice 1406, a high-speed interface 1408 connecting to memory 1404 andhigh-speed expansion ports 1410, and a low speed interface 1415connecting to low speed bus 1414 and storage device 1406. Each of thecomponents 1402, 1404, 1406, 1408, 1410, and 1415, are interconnectedusing various busses, and may be mounted on a common motherboard or inother manners as appropriate. The processor 1402 can processinstructions for execution within the computing device 1400, includinginstructions stored in the memory 1404 or on the storage device 1406 todisplay graphical information for a GUI on an external input/outputdevice, such as display 1416 coupled to high speed interface 1408. Inother implementations, multiple processors and/or multiple buses may beused, as appropriate, along with multiple memories and types of memory.Also, multiple computing devices 1400 may be connected, with each deviceproviding portions of the necessary operations (e.g., as a server bank,a group of blade servers, or a multi-processor system).

The memory 1404 stores information within the computing device 1400. Inone implementation, the memory 1404 is a volatile memory unit or units.In another implementation, the memory 1404 is a non-volatile memory unitor units. The memory 1404 may also be another form of computer-readablemedium, such as a magnetic or optical disk.

The storage device 1406 is capable of providing mass storage for thecomputing device 1400. In one implementation, the storage device 1406may be or contain a computer-readable medium, such as a floppy diskdevice, a hard disk device, an optical disk device, or a tape device, aflash memory or other similar solid state memory device, or an array ofdevices, including devices in a storage area network or otherconfigurations. A computer program product can be tangibly embodied inan information carrier. The computer program product may also containinstructions that, when executed, perform one or more methods, such asthose described herein. The information carrier is a computer- ormachine-readable medium, such as the memory 1404, the storage device1406, memory on processor 1402, or a propagated signal.

The high speed controller 1408 manages bandwidth-intensive operationsfor the computing device 1400, while the low speed controller 1415manages lower bandwidth-intensive operations. Such allocation offunctions is exemplary only. In one implementation, the high-speedcontroller 1408 is coupled to memory 1404, display 1416 (e.g., through agraphics processor or accelerator), and to high-speed expansion ports1410, which may accept various expansion cards (not shown). In theimplementation, low-speed controller 1415 is coupled to storage device1406 and low-speed expansion port 1414. The low-speed expansion port,which may include various communication ports (e.g., USB, Bluetooth,Ethernet, or wireless Ethernet) may be coupled to one or moreinput/output devices, such as a keyboard, a pointing device, a scanner,an optical reader, a fluorescent signal detector, or a networking devicesuch as a switch or router, e.g., through a network adapter.

The computing device 1400 may be implemented in a number of differentforms, as shown in the figure. For example, it may be implemented as astandard server 1420, or multiple times in a group of such servers. Itmay also be implemented as part of a rack server system 1424. Inaddition, it may be implemented in a personal computer such as a laptopcomputer 1422. In some cases, components from computing device 1400 maybe combined with other components in a mobile device (not shown), suchas device 1450. Each of such devices may contain one or more ofcomputing device 1400, 1450, and an entire system may be made up ofmultiple computing devices 1400, 1450 communicating with each other.

Computing device 1450 includes a processor 1452, memory 1464, aninput/output device such as a display 1454, a communication interface1466, and a transceiver 1468, among other components (e.g., a scanner,an optical reader, a fluorescent signal detector). The device 1450 mayalso be provided with a storage device, such as a microdrive or otherdevice, to provide additional storage. Each of the components 1450,1452, 1464, 1454, 1466, and 1468, are interconnected using variousbuses, and several of the components may be mounted on a commonmotherboard or in other manners as appropriate.

The processor 1452 can execute instructions within the computing device1450, including instructions stored in the memory 1464. The processormay be implemented as a chipset of chips that include separate andmultiple analog and digital processors. The processor may provide, forexample, for coordination of the other components of the device 1450,such as control of user interfaces, applications run by device 1450, andwireless communication by device 1450.

Processor 1452 may communicate with a user through control interface1458 and display interface 1456 coupled to a display 1454. The display1454 may be, for example, a TFT LCD (Thin-Film-Transistor Liquid CrystalDisplay) or an OLED (Organic Light Emitting Diode) display, or otherappropriate display technology. The display interface 1456 may compriseappropriate circuitry for driving the display 1454 to present graphicaland other information to a user. The control interface 1458 may receivecommands from a user and convert them for submission to the processor1452. In addition, an external interface 1462 may be provide incommunication with processor 1452, so as to enable near areacommunication of device 1450 with other devices. External interface 1462may provide, for example, for wired communication in someimplementations, or for wireless communication in other implementations,and multiple interfaces may also be used.

The memory 1464 stores information within the computing device 1450. Thememory 1464 can be implemented as one or more of a computer-readablemedium or media, a volatile memory unit or units, or a non-volatilememory unit or units. Expansion memory 1474 may also be provided andconnected to device 1450 through expansion interface 1472, which mayinclude, for example, a SIMM (Single In Line Memory Module) cardinterface. Such expansion memory 1474 may provide extra storage spacefor device 1450, or may also store applications or other information fordevice 1450. For example, expansion memory 1474 may include instructionsto carry out or supplement the processes described herein, and mayinclude secure information also. Thus, for example, expansion memory1474 may be provide as a security module for device 1450, and may beprogrammed with instructions that permit secure use of device 1450. Inaddition, secure applications may be provided via the SIMM cards, alongwith additional information, such as placing identifying information onthe SIMM card in a non-hackable manner.

The memory may include, for example, flash memory and/or NVRAM memory,as discussed below. In one implementation, a computer program product istangibly embodied in an information carrier. The computer programproduct contains instructions that, when executed, perform one or moremethods, such as those described herein. The information carrier is acomputer- or machine-readable medium, such as the memory 1464, expansionmemory 1474, memory on processor 1452, or a propagated signal that maybe received, for example, over transceiver 1468 or external interface1462.

Device 1450 may communicate wirelessly through communication interface1466, which may include digital signal processing circuitry wherenecessary. Communication interface 1466 may provide for communicationsunder various modes or protocols, such as GSM voice calls, SMS, EMS, orMMS messaging, CDMA, TDMA, PDC, WCDMA, CDMA2000, or GPRS, among others.Such communication may occur, for example, through radio-frequencytransceiver 1468. In addition, short-range communication may occur, suchas using a Bluetooth, WiFi, or other such transceiver (not shown). Inaddition, GPS (Global Positioning System) receiver module 1470 mayprovide additional navigation- and location-related wireless data todevice 1450, which may be used as appropriate by applications running ondevice 1450.

Device 1450 may also communicate audibly using audio codec 1460, whichmay receive spoken information from a user and convert it to usabledigital information. Audio codec 1460 may likewise generate audiblesound for a user, such as through a speaker, e.g., in a handset ofdevice 1450. Such sound may include sound from voice telephone calls,may include recorded sound (e.g., voice messages, music files, etc.) andmay also include sound generated by applications operating on device1450.

The computing device 1450 may be implemented in a number of differentforms, as shown in the figure. For example, it may be implemented as acellular telephone 1480. It may also be implemented as part of asmartphone 1482, personal digital assistant, or other similar mobiledevice.

Various implementations of the systems and techniques described hereincan be realized in digital electronic circuitry, integrated circuitry,specially designed ASICs (application specific integrated circuits),computer hardware, firmware, software, and/or combinations thereof Thesevarious implementations can include implementation in one or morecomputer programs that are executable and/or interpretable on aprogrammable system including at least one programmable processor, whichmay be special or general purpose, coupled to receive data andinstructions from, and to transmit data and instructions to, a storagesystem, at least one input device, and at least one output device.

These computer programs (also known as programs, software, softwareapplications or code) include machine instructions for a programmableprocessor, and can be implemented in a high-level procedural and/orobject-oriented programming language, and/or in assembly/machinelanguage. As used herein, the terms “machine-readable medium” and“computer-readable medium” refer to any computer program product,apparatus and/or device (e.g., magnetic discs, optical disks, memory,and Programmable Logic Devices (PLDs)) used to provide machineinstructions and/or data to a programmable processor, including amachine-readable medium that receives machine instructions as amachine-readable signal. The term “machine-readable signal” refers toany signal used to provide machine instructions and/or data to aprogrammable processor.

To provide for interaction with a user, the systems and techniquesdescribed herein can be implemented on a computer having a displaydevice (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display)monitor) for displaying information to the user and a keyboard and apointing device (e.g., a mouse or a trackball) by which the user canprovide input to the computer. Other kinds of devices can be used toprovide for interaction with a user as well; for example, feedbackprovided to the user can be any form of sensory feedback (e.g., visualfeedback, auditory feedback, or tactile feedback); and input from theuser can be received in any form, including acoustic, speech, or tactileinput.

The systems and techniques described herein can be implemented in acomputing system that includes a back end component (e.g., as a dataserver), or that includes a middleware component (e.g., an applicationserver), or that includes a front end component (e.g., a client computerhaving a graphical user interface or a Web browser through which a usercan interact with an implementation of the systems and techniquesdescribed herein), or any combination of such back end, middleware, orfront end components. The components of the system can be interconnectedby any form or medium of digital data communication (e.g., acommunication network). Examples of communication networks include alocal area network (“LAN”), a wide area network (“WAN”), and theInternet.

The computing system can include clients and servers. A client andserver are generally remote from each other and typically interactthrough a communication network. The relationship of client and serverarises by virtue of computer programs running on the respectivecomputers and having a client-server relationship to each other.

The invention will be further described in the following examples, whichdo not limit the scope of the invention described in the claims.

EXAMPLES Example 1 Use of Clindamycin Pre-, Intra-, and Post-operatively

A patient scheduled to undergo a shoulder surgery (e.g., rotator cuffsurgery or shoulder replacement surgery) is instructed to apply a creamcontaining clindamycin to the site of operation at least twice daily for2-7 days prior to the day of surgery. Once in the patient is admitted tothe hospital for the operation, a physician or other medicalprofessional cleans the site of operation and applies a liquidformulation containing clindamycin. After the surgical wound is closed,a physician or other medical professional applies a formulationcontaining clindamycin to the site of operation. In some cases, aphysician or other medical professional applies a patch or othermaterial containing clindamycin to the site of operation. Prior to beingdischarged, the patient or the patient's caregiver is instructed toapply a formulation (e.g., cream) or a patch (or other material)containing clindamycin to the site of operation at least once daily fortwo to 14 days following surgery.

Other Embodiments

It is to be understood that while the invention has been described inconjunction with the detailed description thereof, the foregoingdescription is intended to illustrate and not limit the scope of theinvention, which is defined by the scope of the appended claims. Otheraspects, advantages, and modifications are within the scope of thefollowing claims.

What is claimed is:
 1. A method for reducing risk of a post-operativePropionibacterium acnes infection following a shoulder surgery, whereinsaid method comprises: a) applying a first topical antibacterialcomposition to at least a portion of an operative site at least dailyfor two or more days before said shoulder surgery, and b)intra-operatively applying a surgical drape comprising a second topicalantibacterial composition to at least a portion of the operative site,wherein the first and second topical antibacterial compositions compriseclindamycin, erythromycin, or a combination thereof.
 2. The method ofclaim 1, wherein said shoulder surgery is selected from the groupconsisting of rotator cuff surgery, shoulder replacement surgery,instability surgery of the shoulder, clavicle fracture surgery, proximalhumerus fracture surgery, and mid-shaft humerus fracture surgery.
 3. Themethod of claim 1, wherein said first topical antibacterial compositionis applied using a deodorant applicator.
 4. The method of claim 1,wherein said first topical antibacterial composition is applied bywiping the skin with a wipe impregnated with said first topicalantibacterial composition.
 5. The method of claim 1, wherein said methodfurther comprises dressing said surgical site post-operatively withdressings that are impregnated with a third topical antibacterialcomposition comprising clindamycin.
 6. The method of claim 5, whereinfirst, second, or third topical antibacterial composition furthercomprises clindamycin or erythromycin and a second antibiotic.